- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07255339
The Effect of Music Therapy on Pain and Anxiety in Patients After Coronary Artery Bypass Grafting
Study Overview
Status
Intervention / Treatment
Detailed Description
Coronary artery disease (CAD) has remained one of the leading causes of high morbidity and mortality both in our country and worldwide over the past five years. According to global epidemiological data, cardiovascular diseases account for nearly one-third of all deaths, making them a major public health concern. CAD is characterized by atherosclerotic plaque formation and the narrowing of coronary vessels, which results in reduced myocardial oxygenation. As the disease progresses, coronary artery bypass grafting (CABG) becomes one of the most commonly used and effective treatment methods. The primary goal of CABG is to restore myocardial blood flow distal to the stenotic or occluded coronary artery by using arterial or venous grafts, thereby improving cardiac perfusion and enhancing both quality of life and overall survival.
CABG is a major surgical intervention that imposes significant psychological, physiological, social, and economic burdens on patients. In the postoperative period, patients frequently experience severe pain, anxiety, sleep disturbances, stress, depressive symptoms, hemodynamic instability, and reduced quality of life. The intensity of postoperative pain is affected by the invasiveness of the procedure, such as sternotomy, placement of chest tubes, surgical drains, and limited mobility. Moreover, undergoing a surgical procedure involving the heart-a vital organ-often triggers fear of death, a sense of loss of control, uncertainty about recovery, and concerns about postoperative complications, all of which contribute to heightened anxiety levels.
While pharmacological treatments are essential in managing postoperative pain and anxiety, they are often insufficient on their own. For this reason, non-pharmacological interventions are increasingly recommended as complementary approaches during the recovery process. Among these interventions-such as breathing exercises, relaxation techniques, massage therapy, and aromatherapy-music therapy has gained particular attention due to its demonstrated benefits.
Music therapy is a specialized, evidence-based discipline that utilizes the therapeutic elements of music within a structured patient-therapist relationship to support the individual's physical, psychological, and spiritual well-being. By employing components such as rhythm, melody, and harmony, music therapy aims to regulate emotional responses and promote healing. Studies have shown that music has significant effects on the autonomic nervous system; it activates the parasympathetic system, helping to stabilize heart rate, reduce blood pressure, regulate breathing, and decrease levels of stress-related hormones, including cortisol. Consequently, music therapy alleviates both the perception of pain and anxiety.
Furthermore, disruptions in sleep patterns prior to surgery can exacerbate anxiety and pain, while chronic stress and elevated stress hormones may negatively affect heart rate, oxygen demand, and overall cardiopulmonary stability. Previous research has demonstrated that music therapy can help regulate the mind-body-spirit connection within the endocrine and nervous systems, thereby promoting physiological balance and emotional comfort in individuals undergoing major surgical procedures such as CABG.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Van, Turkey (Türkiye)
- SB.SBÜ. Van Eğitim ve Araştırma Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients over 18 years of age with no hearing impairment
- Planned for coronary artery bypass graft surgery
- Not diagnosed with a psychiatric disorder and therefore not taking medication
- Volunteer to participate in the study
Exclusion Criteria:
- Patients who refuse to participate in the study
- Patients who volunteer to participate and then withdraw from the study at any stage.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
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Active Comparator: Music therapy group
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In the study, patients undergoing coronary artery bypass graft surgery will be exposed to music before and during surgery.
The Beck Anxiety Inventory and Visual Analog Scale will be administered postoperatively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of music played on anxiety in patients undergoing coronary artery bypass graft surgery
Time Frame: From enrollment to the end of treatment at one years
|
"Not at all" indicates no anxiety at all, while "I had a very hard time tolerating it at a serious level" indicates the highest possible anxiety.
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From enrollment to the end of treatment at one years
|
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The effect of music played on pain in patients undergoing coronary artery bypass graft surgery
Time Frame: From enrollment to the end of treatment at one years
|
Zero is equivalent to no pain, and 10 indicates the worst possible pain
|
From enrollment to the end of treatment at one years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/17-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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